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Guide on Oxymetazoline HCl ANDAs

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Draft Guidance on Oxymetazoline Hydrochloride.

FDA Developing New Drug Safety Tools: Dal Pan

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CDER Office of Surveillance and Epidemiology director Gerald J. Dal Pan says FDA is developing new tools to help identify drug pos...

Baxter Novum IQ Large Volume Pump Cleared

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FDA clears a Baxter International 510(k) clearance for its Novum IQ large volume infusion pump with Dose IQ safety software.

AstraZenecas Voydeya OKd for Hemolysis

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FDA approves AstraZenecas Voydeya (danicopan) as an add-on therapy to Ultomiris (ravulizumab) or Soliris (eculizumab) for treating...

Eisai sBLA for Monthly Alzheimers Maintenance

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Eisai files a supplemental BLA for monthly Leqembi (lecanemab-irmb) intravenous maintenance dosing in Alzheimers disease patients....

FDA Guide on Safety Report e-Submissions

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FDA posts a final guidance entitled Electronic Submission of Expedited Safety Reports From IND-Exempt BA/BE Studies.

IND Safety Report eSubmissions Guide

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Federal Register notice: FDA makes available a final guidance entitled Providing Regulatory Submissions in Electronic Format: IND ...

FDA Clears Abbotts Concussion Blood Test

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FDA clears Abbotts i-STAT TBI (traumatic brain injury) cartridge to be used with whole blood to assess patients with suspected con...

PhRMA Seeks Specificity for Cell Product Potency Guide

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Pharmaceutical Research and Manufacturers of America says FDAs recent draft guidance on cell and gene therapy potency assurance ne...

FDA Clears Digital Therapeutic for Depression

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FDA clears an Otsuka Pharmaceutical and Click Therapeutics 510(k) for Rejoyn, a prescription digital therapeutic authorized for tr...